IV Administration Set 470005Recalls & reported problems
B. Braun Medical Inc. · IV SET 15DR 3 CARESITE, 124 IN. · Class 2
All models of IV Administration Set (153)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04046964297199), received between Jan 10, 2019 and Jan 10, 2019 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (15 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0658-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak15
Patient problems
- No Known Impact Or Consequence To Patient15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 4: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232898 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 12: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232894 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 1: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232886 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 8: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232885 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 3: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232884 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 2: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232880 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 7: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232879 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 14: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232877 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 5: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232876 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 9: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232875 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 6: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232873 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 15: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232871 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 11: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232869 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 10: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232868 ↗MalfunctionJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak
EVENT 13: AS REPORTED BY THE USER FACILITY: ABOUT 12-15 SETS HAVE COME APART DURING SURGERY CAUSING BLOOD LEAKAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8232867 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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